Viscosupplementation Therapy For Knee

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Viscosupplementation Therapy for Knee. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Viscosupplementation Therapy for Knee and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
  • Chapter 15, Section 50.1 Definition of Drug or Biological, Section 50.2 Determining Self-Administration of Drug or Biological, paragraph (K) Reasonable and Necessary, Section 50.3 Incident-to Requirements, and Section 50.4 Reasonable and Necessary
• CMS IOM Publication 100-08, Medicare Program Integrity Manual,
  • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 
• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

History/Background and/or General Information

Viscosupplementation therapy is part of the therapy used in the treatment of osteoarthritis of the knee. Osteoarthritis results from articular cartilage failure due to the complex interplay of genetic, metabolic, biochemical and biomechanical factors with a secondary component of inflammation. In most patients the initiating mechanism is damage to the articular cartilage either as a single large injury or a series of repeated smaller injuries. The primary symptom of osteoarthritis of the knee is pain, however, because cartilage is aneural, significant radiographic findings are often noted in asymptomatic individuals imaged for other reasons.

Synthetic hyaluronic preparations used as a viscosupplement are indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics such as acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDS).

Covered Indications

Viscosupplementation therapy for the knee via intra-articular injections of hyaluronic preparations will be considered medically reasonable and necessary when ALL of the following conditions are met:

• The patient is symptomatic. Such symptoms may include pain which interferes with the activities of daily living such as ambulation and prolonged standing, or pain interrupting sleep, crepitus, and/or knee stiffness 
• The clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as joint space narrowing, subchondral sclerosis, osteophytes and sub-chondral cysts
• If appropriate, other diagnoses have been excluded by appropriate evaluation and management services, laboratory and imaging studies (i.e. the pain and functional disability is not considered likely to be due to a diagnosis other than osteoarthritis of the knee.)
• The patient has failed at least three months of conservative therapy. Conservative therapy is defined as:
  • Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, physical therapy if indicated); and
  • If not contraindicated, simple analgesics and NSAIDS.
• The patient has failed to respond to aspiration of the knee and intra-articular corticosteroid injection therapy when inflammation is a significant component of the patient’s symptoms and intra-articular corticosteroids are not contraindicated.

Limitations

1. Drugs and biologicals approved for marketing by the FDA are considered safe and effective when used for indications specified on the labeling. The labeling lists the safe and effective, i.e., medically reasonable and necessary dosage and frequency. Therefore, doses and frequencies that exceed the accepted standard of recommended dosage and/or frequency, as described in the package insert, are considered not reasonable and necessary and therefore, not subject to coverage.
2. Intra-articular injections of other therapeutic agents, such as corticosteroids, should not be performed in the same knee during the course of viscosupplementation therapy.
3. If the first course of treatment produces relief, subsequent courses of treatment may be reasonable if symptoms return. Subsequent courses of treatment will be allowed six (6) months after the last injection of a previous course of treatment.
4. Viscosupplementation of joints other than the knee(s) will be considered not reasonable and necessary and will not be subject to coverage. 
5. Imaging procedures performed routinely for the purpose of visualization of the knee to provide guidance for needle placement will not be covered. Fluoroscopy may be medically necessary and allowed if documentation supports that the presentation of the patient’s affected knee on the day of the procedure makes needle insertion problematic. No other imaging modality for the purpose of needle guidance and placement will be covered.
6. Arthrography to provide needle guidance for knee injections will not be covered.
7. Coverage of viscosupplementation therapy of the knee assumes that knee arthroplasty is not being considered as a current treatment option.
8. The course of treatment should consist of the use of one agent. One agent should be used for the entire course of treatment. Therefore, initiating a course of treatment with one agent, then switching before completion to a different agent is considered not medically reasonable and necessary. Example: Treatment is initiated with Synvisc. After the application of two doses, the provider switches to Synvisc-one. The Synvisc-one would not be considered medically reasonable and necessary.
9. It is not expected that routine imaging for the purpose of needle guidance would be required. Therefore, routine use of fluoroscopy may result in a pre- payment medical review of records. Documentation should provide justification when imaging is performed for the purpose of needle guidance. The use of hand held ultrasound devices are not separately reimbursed.
10. Viscosupplementation will not be covered:
    • When the diagnosis is anything other than osteoarthritis
    • For intra-articular injection in joints other than the knee
    • As the initial treatment of osteoarthritis of the knee
    • When failure of/or contraindication to conservative therapy and/or corticosteroid injections are not documented in the medical record
    • When the dose and treatment regimen exceeds those approved under the FDA label
    • When a repeat series of injections is initiated prior to six months after completion of the previous course of treatment
    • When a repeat series of injections is administered when there was no symptomatic/functional improvement evidenced from the previous series of injections
    • For topical application of hyaluronate preparations

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

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Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Viscosupplementation Therapy for Knee (A57256) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Viscosupplementation Therapy for Knee (A57256) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

First Coast Service Options, Inc., reference LCD number(s) – L29037, L29307, L29408

1. American College of Rheumatology. Joint injection/aspiration Accessed September 20, 2005. 
2. Brandt KD, and Dieppe P. What is important in treating osteoarthritis? Whom should we treat and how should we treat them? Rheum Dis Clin N Am. 2003;29(4):687-716. 
3. ESRI Windows on Medical technology: “Hyaluronan-based Therapy for Osteoarthritis of the Knee". September 2001. 
4. Hall S, Buchbinder R. Do imaging methods that guide needle placement improve outcome? Ann Rheum Dis. 2004; 63(9):1007-1008. 
5. Harris E. Overview of imaging modalities. Kelley’s Textbook of Rheumatology, 7th ed., Elsvier. 2005. Accessed September 16, 2005. 
6. Hyalgan® Sodium Hyaluronate [package insert]. New York, NY: Sanofi Pharmaceuticals, Inc.; 2001. 
7. Hymovis® High Molecular Weight Viscoelastic Hyaluronan (HYADD4®) [package insert]. Brookline, MA: Fidia Farmaceutici S.p.A. 2015. 
8. Jackson D. Viscosupplementation: Importance of Intra-articular needle placement. 2007. Accessed July 17, 2008.
9. Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone and Joint Surg, Inc. 2002;84-A(9):1522-1527. 
10. Jubb RW, Piva S, Beinat L, Dacre J, Gishen P. A one-year, randomized, placebo (saline) controlled clinical trial of 500-730 kda sodium hyaluronate (Hyalgan®) on the radiological change in osteoarthritis of the knee. Int J Clin Practice. 2003;57(6):467-474. 
11. Kolarz G, Kotz R, Hochmayer I. Long-term benefits and repeated treatment cycles of intra-articular sodium hyaluronate (Hyalgan®) in patients with osteoarthritis of the knee. Semin Arthritis and Rheum. 2003; 32(5):310-319. 
12. Neustadt DH. Long-term efficacy and safety of intra-articular sodium hyaluronate (Hyalgan®) in patients with osteoarthritis of the knee. Clin Exp Rheumatol. 2003;21:(3)307-311. 
13. Orthovisc® High molecular weight Hyaluronan [package insert]. Rarita, NJ: OrthoBiotech Products, L.P. 2004. 
14. SupartzTM Sodium Hyaluronate [package insert]. Memphis, TN: Smith & Nephew, Inc. 2000. 
15. Synvisc® Hylan G-F 20 [package insert]. Philadelphia, PA: Wyeth-Ayerst Pharmaceuticals. 2000. 
16. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data (SSED): Gel-One®. 2011. Accessed April 03, 2012 
17. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data Monovisc™. 2014. Accessed September 09, 2014. 
18. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data (SSED): Durolane®. 2017. Accessed December 13, 2018. 
19. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data (SSED): TriVisc™. 2017. Accessed December 13, 2018. 
20. S. Food and Drug Administration (FDA). Product information GEL-SYN™. 2014. Accessed November 17, 2016.
21. U.S. Food and Drug Administration (FDA). Full prescribing information GenVisc® 850. (Adant®). 2015. Accessed November 17, 2016.
22. U.S. Food and Drug Administration (FDA). Product information VISCO-3™. 2015. Accessed November 27, 2017.
23. U.S. Food and Drug Administration (FDA). Product information SYNOJOYNT™. 2018. Accessed September 06, 2019.
24. U.S. Food and Drug Administration (FDA). Product information TRILURON™. 2019. Accessed September 06, 2019.

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